Regulatory Updates
Sep 2, 2026•1 min read
FDA Grants ANDA206666 Approval for Pentamidine Isethionate Injection
FDA approved ANDA206666 for Pentamidine Isethionate injectable, a prescription drug administered intramuscularly or intravenously.
Regulatory Updates
Sep 2, 2026•1 min read
FDA approves five new products in June, spanning cell therapy to biosimilars
The FDA granted approvals for five products in June—including a cell therapy, rare‑disease drug, antibiotic, imaging contrast agent and a biosimilar—signaling trends in advanced biopharma.
Regulatory Updates
Sep 1, 2026•1 min read
FDA Temporarily Suspends CRL Publication Policy
The FDA has paused its real‑time release of complete response letters after a citizen petition, with HHS reviewing the procedure.
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Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves RESTORIL (Temazepam) Capsules – NDA018163
The FDA has approved RESTORIL, a prescription oral temazepam capsule from SpecGx LLC, available in 7.5‑30 mg strengths under application NDA018163.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 084030 for Amosene 400 mg Meprobamate Tablet
The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA083389 for Lidocaine Hydrochloride with Epinephrine Injection (Discontinued)
The FDA approved ANDA083389 for a lidocaine hydrochloride 1% injection containing 0.01 mg/mL epinephrine, submitted by Dell Labs; the product is listed as discontinued.
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Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Multiple Submissions for CYCLOCORT Topical Cream (NDA018116)
The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.
Regulatory Updates
Aug 31, 2026•1 min read
FDA ANDA089606: Watson Labs' PROCHLORPERAZINE EDISYLATE Injection Discontinued
The FDA’s ANDA089606 filing for Watson Labs’ prochlorperazine edisylate injectable is listed as discontinued, detailing route, dosage form, and active ingredient.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Discontinues ANDA089249 for NANDROLONE DECANOATE Injection
The FDA has listed the ANDA089249 application for NANDROLONE DECANOATE injectable by Quad Pharms as discontinued, noting its marketing status and product details.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 088872 for Thioridazine Hydrochloride Tablet (Discontinued)
The FDA has approved ANDA 088872 for an oral tablet of thioridazine hydrochloride (200 mg) submitted by Watson Labs Teva, though the product is listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)
FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Issues ANDA078545 Approval for Discontinued Lamivudine Tablet Products
The FDA’s ANDA078545 submission by Pharmobedient lists two oral lamivudine tablets (150 mg and 300 mg) that are marked as discontinued, with an approval status dated March 5 2019.